University of Pittsburgh Cancer Institute (UPCI)

Overview

The University of Pittsburgh Cancer Institute (UPCI) Investigational Drug Services (IDS) oversees all pharmacy procedures and processes for UPCI and clinical sites where UPCI sponsored studies are implemented. The service is responsible for coordinating and managing the investigational drug inventory, storage, distribution, and record keeping for UPCI clinical research studies. The IDS facilitates the conduct of early phase clinical trials throughout the network sites by developing strategies for drug preparation and delivery in sites that are not currently involved in clinical trials. All protocols are reviewed by IDS pharmacists early in the developmental phase to identify any IDS related issues (including the pharmaceutical and clinical pharmacy requirements). Reviews include an assessment of drug handling issues, implementation requirements, development of procedures for drug preparation at each treatment site, and impact of study-related drug costs on protocol development and implementation.

The IDS is also responsible for the education of pharmacists and pharmacy technicians throughout the network who will be handling the drugs or agents for each protocol. The IDS develops appropriate processes for drug handling and preparation at new clinical sites. The IDS is also responsible for:

• Drug management
• Investigational drug supply (including development of protocol-specific and site-specific pharmacy drug management procedures)
• Development and/or adaptation of protocol specific guidelines for written medication or medications used in the clinical studies
• Maintaining all investigational medications in secured areas of clinical sites
• Maintaining drug accountability records for investigational medications
• Coordination of medication distribution to the clinical sites involved in clinical studies
• Routine quality assurance of drug handling

Quality assurance includes monitoring of drug accountability records, a coding system, and a system for labeling investigation drugs with new expiration notices. The IDS provides important infrastructure support for the coordination of studies within the UPMC Cancer Centers network and works with each clinical site to develop the appropriate implementation plan on a protocol-by-protocol basis.